Familial Hypercholesterolemia News and Research

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Impax confirms initiation of challenge of patents listed by MSP Singapore for VYTORIN

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by MSP Singapore Co. LLC in connection with VYTORIN® (ezetimibe/simvastatin), 10 mg/80 mg.

21 Aug 2010

Isis second-quarter pro forma net operating loss increases to $15.5 million

Isis Pharmaceuticals, Inc. today announced its financial results for the quarter ended June 30, 2010. The Company finished the second quarter of 2010 with a pro forma net operating loss (NOL) of $15.5 million and $17.1 million for the three and six months ended June 30, 2010, respectively, compared to a pro forma net operating loss of $1.3 million and pro forma net operating income of $798,000 for the same periods of 2009.

9 Aug 2010

Genzyme, Isis announce results of two mipomersen phase 3 studies

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo.

5 Aug 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

Genzyme second-quarter revenue decreases to $1.08 billion

Genzyme Corp. today reported that second-quarter revenue was $1.08 billion, compared with $1.23 billion in the same period last year, reflecting limited shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) due to product supply constraints in 2010. The company expects to be able to increase shipments of Cerezyme and Fabrazyme during the second half of the year.

21 Jul 2010

Pfizer's new chewable Lipitor for children receives European Commission approval

Pfizer Inc. announced it has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.

7 Jul 2010

GSK, Isis Pharmaceuticals collaborate to develop new therapeutics for rare and serious disease

GlaxoSmithKline and Isis Pharmaceuticals, Inc. announced today a new strategic alliance that will apply the Isis antisense drug discovery platform to seek out and develop new therapeutics against targets for rare and serious disease, including infectious diseases and some conditions causing blindness.

31 Mar 2010

Genzyme, Isis Pharmaceuticals: Phase 3 study of mipomersen in hoFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that data from a phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were published in The Lancet. This study met its primary endpoint, resulting in an average LDL-C reduction of greater than 100 mg/dL in this very high-risk patient population.

16 Mar 2010

Isis Pharmaceuticals reports revenues of $32.3M for fourth-quarter 2009

Isis Pharmaceuticals, Inc. today announced its 2009 financial results and reviewed the highlights of the year. Isis achieved its 2009 financial guidance with pro forma net income of $166.9 million and a pro forma net operating loss (NOL) of $14.2 million compared with its guidance for the year of pro forma net income of more than $145 million and a pro forma NOL in the low to mid $20 million range. Isis also achieved its cash guidance by ending 2009 with $574.3 million of cash, cash equivalents and short-term investments significantly in excess of the $550 million projected.

1 Mar 2010

Genzyme announces fourth-quarter and full-year 2009 financial results

Genzyme Corp., a diversified, global biotechnology company, today announced fourth-quarter and full year 2009 financial results and provided 2010 guidance that reflects growth across its businesses and a focus on strengthening core areas of the company.

18 Feb 2010

Pediatric data for Pfizer's Lipitor submitted to the EMEA

Pfizer Inc announced it has submitted pediatric data for Lipitor® (atorvastatin) to the European Medicines Agency (EMEA). Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is part of this submission.

18 Nov 2009

Genzyme and Isis Pharmaceuticals announce phase 3 study data of mipomersen

Genzyme Corp. and Isis Pharmaceuticals Inc. announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented today at the American Heart Association’s Scientific Sessions.

17 Nov 2009

Additional data from Aegerion Pharmaceuticals' ongoing lomitapide Phase III trial

Aegerion Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of cardiovascular and metabolic disease, today announced additional data from its ongoing Phase III trial involving its lead cholesterol management compound, lomitapide (AEGR-733), which is a microsomal triglyceride transfer protein (MTP) inhibitor small molecule drug.

16 Nov 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

FDA approves Daiichi Sankyo's sNDA for Welchol

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

7 Oct 2009

Drug pactimibe does not appear to reduce progression of atherosclerosis

Compared to placebo, the drug pactimibe did not effect certain measures of atherosclerosis for patients with familial hypercholesterolemia (high cholesterol levels), but these patients did have an increased incidence of cardiovascular events such as heart attack and stroke, according to a study in the March 18 issue of JAMA.

17 Mar 2009

Major discovery in the control of bad cholesterol

A study performed by the team of Dr. Nabil G. Seidah, Director of the Biochemical Neuroendocrinology Research Unit at the IRCM, shows for the very first time that the degradation by PCSK9 of the LDLR receptor, which is responsible for removing the bad cholesterol (LDL-cholesterol) from the bloodstream, may be inhibited by a third protein, annexin A2.

24 Nov 2008

Issues on cholesterol: diet, statins and genetics

Genetic lipoprotein disorders are frequently seen in patients with premature coronary artery disease (CAD). An example of strong genetic predisposition is the disorder: familial hypercholesterolemia, where a single gene defect (the low density lipoprotein receptor) contributes to most of the familial expression of CAD.

1 Sep 2008

Lipid Association responds to new cholesterol guidelines for kids

When the American Academy of Pediatrics (AAP) issued its recommendation on July 7 regarding the treatment of children with high cholesterol, it generated a strong response from the community of medical professionals and patients. The National Lipid Association (NLA), a group of healthcare professionals who specialize in cholesterol and heart disease issues, believes that the AAP has acted in the interests of patient care by raising the issue of lipid abnormalities in children.

10 Jul 2008

Improving statins

Statin drugs are helping many people lower their cholesterol, but a new study in the February Journal of Lipid Research reveals that statins actually increase the production of another protein that limits their benefit.

8 Feb 2008